Data Foundry

Medical device recalls 2021

These are communication systems — Class II medical device recall Z-0402-2022

Terminated recall by Hill-Rom Inc., reported 2021-12-29, distributed nationwide. An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-function

Recall numberZ-0402-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHill-Rom Inc., Cary, NC, United States
Recall initiated2021-10-14
Classified2021-12-20
Reported by FDA2021-12-29
Terminated2024-08-16
DistributedNationwide (US)
Quantity1,050 units
UPC / GTIN / UDI-DI00887761001541, 00887761021198, 00887761985209, 00887761995079
Model numbers3.6, 3.7, 3.9, 4.0

Product

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020

Reason for recall

An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0402-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.